World Trade Organization Organisation Mondiale du Commerce Organización Mundial del Comercio

1. Soaps and detergents
2. Paper
3. Food items	4. Lubricating oils
5. Packaging material/package	6. Architectural paints and powder
7. Batteries	8. Electrical/electronic goods
9. Food additives	10. Wood substitutes
11. Cosmetics	12. Aerosol propellants
13. Plastic products	14. Textiles
15. Fire extinguishers	16. Leather

Drugs and Cosmetic Rules 2007

The amendment to the Drugs and Cosmetic Rules for introducing a system of registration of imports of cosmetics into the country was published as a Gazette notice dated 2.2.2007. It was subsequently notified to the WTO on 15.4.2008 vide notification no G/TBT/N/IND/33. A subsequent Gazette notice was made on 19.5.2010 with a later amendment dated 19.7.2010 indicating the specific date of entry into force. Based on an extension granted, these rules are now to come into effect on 1.10.2011. Therefore, the transparency obligations under the TBT Agreement namely the reasonable time period for other members to make comments and providing a reasonable interval between its publications and entry into force have been met.

This notification is based purely on public health concerns of the consumers. The provisions of the amendment do not discriminate between the exporters to India as similar provisions are already in existence for domestic manufactures. A system of registration of imports of Drugs was already in practice since 2003.

The amended rules also take on board the concerns of some Members with the deletion of the clause related to inspection or visit of the manufacturer premises by the licensing authority in India or by any other person to whom the power has been delegated.

US 58:

Report by the Secretariat (WT/TPR/S/249):III. TRADE POLICIES AND PRACTICES BY MEASURE: (2) Measures Directly Affecting Imports: (ix) Technical regulations and standards: Page 68, paragraph 103:

Since August 2007, India has notified a total of nine (9) new measures to the WTO TBT Committee plus one (1) supplemental notice, for a total of ten (10) notifications over the course of four years. During the same period, China notified a total of 561 measures; Brazil: 185 measures; and Kenya: 178 measures. How does India explain its extremely low relative number of TBT notifications?

Reply: Regulations, standards and conformity assessment procedures thereof are formed or changes are made therein according to the need of domestic industry, consumer safety and socio economic developments. As and when changes are made in existing regulations or standards and conformity assessment procedures thereof or new regulation or standard and conformity assessment procedures are drafted, this is duly notified to the WTO as per transparency obligations prescribed in the SPS and TBT Agreements.

US 59:

Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (2) Measures Directly Affecting Imports: (ix) Technical regulations and standards: Page 68, paragraph 104:

According to the Secretariat: "A draft technical regulation is sent out for comments prior to its adoption by the concerned ministry/department/organization and publication in the Official Gazette. Comments must be provided within 60 days of the publication of the notice. The draft technical regulations are also notified to WTO Members for comments." Since August 2007, India's Ministry of Health sent 121 notices to the Official Gazette; India Ministry of Environment and Forests: 69 notices; India Ministry of Consumer Affairs, Food, and Public Distribution: 59 notices. In sum, just these three individual ministries sent 249 notices to the Official Gazette. Please describe in detail the process by which India notifies measures to the WTO Secretariat. What actions is India taking (or planning to take) to improve the regulatory coordination required to notify the WTO of its many technical regulations and conformity assessment procedures?

Reply: During 2007 to 2011 India has notified 40 SPS and TBT notifications to the WTO. Whenever any department/ministry or regulatory body makes any changes in the existing regulation or standard and conformity assessment procedures thereof or drafts a new regulation or standard and conformity assessment procedures, they are notified to the WTO.

US 60:

Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (2) Measures Directly Affecting Imports: (ix) Technical regulations and standards: Pages 68 69, paragraphs 103 105:

We understood that India would ensure that import licenses will be issued at the same time that the medical devices registrations are approved. India seems to have a three month processing lag. How does India plan to address these issues expeditiously, which may include providing adequate staff in the Drugs Controller General of India's office to implement the registration requirements?

Reply: Grant of registration certificate and grant of import license are separate exercises under the Drugs and Cosmetics Rules. Applications for grant of import license have to be processed subsequent to the approval of registration certificate as one of the pre condition of application is the grant of registration certificate. Many times authorised importer different from the registration certificate holder. To expedite the processing of applications the office of DCGI is being strengthened.

US 61:

Report by the Secretariat (WT/TPR/S/249): III. TRADE POLICIES AND PRACTICES BY MEASURE: (2) Measures Directly Affecting Imports: (ix) Technical regulations and standards: Pages 68 69, paragraphs 103 105:

When does India plan to establish a regime that distinguishes between medical technologies and pharmaceuticals; and, how will India provide the time required for both industry and India's regulators to prepare for compliance with and implementation of any new rules?